Product Code: LGD FDA class 2 21 CFR 866.3780

Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

Microbiology

An enzyme-linked immunosorbent assay (ELISA) for Toxoplasma gondii is a laboratory diagnostic test used to detect antibodies to Toxoplasma gondii in patient serum, supporting diagnosis of toxoplasmosis, a parasitic infection of particular clinical concern in immunocompromised individuals and during pregnancy. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. It carries product code LGD and is regulated under 21 CFR 866.3780 within the Microbiology specialty. This device is eligible for third-party review.

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510(k)s

106

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: LGD
Device Class: FDA class 2
Regulation Number: 866.3780
Medical Specialty: Microbiology
Review Panel: MI
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 106 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K242022	Access Toxo IgG	Mar 28, 2025	Substantially Equivalent	Beckman Coulter, Inc.
K242095	Access Toxo IgM II	Oct 11, 2024	Substantially Equivalent	Beckman Coulter, Inc.
K233932	Alinity i Toxo IgM	Aug 30, 2024	Substantially Equivalent	Abbott Laboratories
K210596	ARCHITECT Toxo IgG	May 19, 2022	Substantially Equivalent	Abbott Laboratories
K162678	Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl	Jun 23, 2017	Substantially Equivalent	Roche Diagnostics
K142826	ADVIA Centaur Toxoplasma M (Toxo M)	Dec 22, 2015	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K132234	LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II	Aug 28, 2013	Substantially Equivalent	DiaSorin, Inc.
K131441	LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II	Aug 09, 2013	Substantially Equivalent	DiaSorin, Inc.
K101946	VIDAS TOXO IGG AVIDITY	May 18, 2011	Substantially Equivalent	bioMerieux, Inc.
K102681	ADVIA CENTAUR TOXOPLASMA IGG (TOXO G)	May 04, 2011	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K090847	PLATELIA TOXO IGM KIT MODEL 26211	Jul 01, 2009	Substantially Equivalent	Bio-Rad Laboratories
K073501	ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG	Jun 09, 2008	Substantially Equivalent	Roche Diagnostics Corp.
K080869	ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC	May 23, 2008	Substantially Equivalent	Beckman Coulter, Inc.
K052499	DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS	Feb 08, 2006	Substantially Equivalent	Diasorin S.P.A
K032162	ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY	Aug 08, 2003	Substantially Equivalent	Beckman Coulter, Inc.
K031506	ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY	Jun 02, 2003	Substantially Equivalent	Beckman Coulter, Inc.
K013839	BIO-RAD PLATELIA TOXO IGG TMB	Sep 30, 2002	Substantially Equivalent	Bio-Rad
K013837	BIO-RAD PLATELIA TOXO IGM TMB	Sep 30, 2002	Substantially Equivalent	Bio-Rad
K012075	IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTM6	Jan 10, 2002	Substantially Equivalent	Diagnostic Products Corp.
K012183	BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY	Dec 27, 2001	Substantially Equivalent	Bayer Diagnostics Corp.
K010755	BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAY	Aug 20, 2001	Substantially Equivalent	Bayer Corp.
K003259	ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 34470,34475,34479	Jun 13, 2001	Substantially Equivalent	Beckman Coulter, Inc.
K002453	ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 34470, 34475, AND 34479	Aug 31, 2000	Substantially Equivalent	Beckman Coulter, Inc.
K001707	DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM	Jul 07, 2000	Substantially Equivalent	Diamedix Corp.
K993319	VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210	May 22, 2000	Substantially Equivalent	bioMerieux, Inc.
K984317	THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)F	Jan 22, 1999	Substantially Equivalent	Zeus Scientific, Inc.
K984170	THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGM ELISA TEST SYSTEM	Jan 19, 1999	Substantially Equivalent	Zeus Scientific, Inc.
K973448	ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469	Sep 17, 1998	Substantially Equivalent	Beckman Instruments, Inc.
K981498	IS-TOXOPLASMA IGG TEST SYSTEM	Aug 21, 1998	Substantially Equivalent	Diamedix Corp.
K971441	QUANTA LITE TOXOPLASMA IGG	Dec 02, 1997	Substantially Equivalent	Inova Diagnostics, Inc.
K971989	TOXOPLASMA IGM ASSAY FOR THE BAYER IMMUNO1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)	Oct 22, 1997	Substantially Equivalent	Bayer Corp.
K971672	SERAQUEST TOXOPLASMA IGM	Oct 21, 1997	Substantially Equivalent	Quest Intl., Inc.
K963289	INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY	May 01, 1997	Substantially Equivalent	Incstar Corp.
K962936	IMMULITE TOXOPLASMA QUANTITATIVE IGG	Apr 24, 1997	Substantially Equivalent	Diagnostic Products Corp.
K962343	TOXO IGG ELISA TEST	Mar 24, 1997	Substantially Equivalent	Gull Laboratories, Inc.
K963297	INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560)	Dec 16, 1996	Substantially Equivalent	Incstar Corp.
K963296	INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565)	Dec 16, 1996	Substantially Equivalent	Incstar Corp.
K954576	AXSYM TOXO IGM	Aug 23, 1996	Substantially Equivalent	Abbott Laboratories
K954575	AXSYM TOXO IGG ANTIBODY ASSAY	Aug 16, 1996	Substantially Equivalent	Abbott Laboratories
K955760	TOXOPLASMA IGG IN-VITRO DIAGNOSTIC SYSTEM	Aug 02, 1996	Substantially Equivalent	Bayer Corp.
K960092	SERAQUEST TOXOPLASMA IGG	Jun 17, 1996	Substantially Equivalent	Quest Intl., Inc.
K944867	TOXOSTAT	May 14, 1996	Substantially Equivalent	Bio-Whittaker, Inc., A Cambrex Co.
K950671	IMMULITE TOXOPLASMA GONDII IGG	Feb 23, 1996	Substantially Equivalent	Diagnostic Products Corp.
K951495	ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM	Dec 20, 1995	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K951636	IMX TOXO IGG	Aug 01, 1995	Substantially Equivalent	Abbott Laboratories
K945634	IMX(R) TOXO IGM	Apr 27, 1995	Substantially Equivalent	Abbott Laboratories
K931334	VIDAS TOXO COMPETITION (TXC) ASSAY	Jun 21, 1993	Substantially Equivalent	Biomerieux Vitek, Inc.
K922737	VIDAS TOXO IG6 ASSAY (TX6)	May 11, 1993	Substantially Equivalent	Biomerieux Vitek, Inc.
K923166	VIDAS TOXOPLASMA GONDII IGM ASSSAY	Feb 25, 1993	Substantially Equivalent	Biomerieux Vitek, Inc.
K921523	OPUS(R) TOXO-G TEST SYSTEM	Sep 14, 1992	Substantially Equivalent	Pb Diagnostics, Inc.
K922585	BARTELS TOXOPLASMA IGG EIA	Sep 02, 1992	Substantially Equivalent	Baxter Diagnostics, Inc.
K922579	BARTELS TOXOPLASMA IGM EIA	Sep 02, 1992	Substantially Equivalent	Baxter Diagnostics, Inc.
K920702	TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO	Jul 08, 1992	Substantially Equivalent	Pharmacia Diagnostics, Inc.
K913731	ENZYGNOST(R) TOXOPLASMOSIS/IGG	Apr 29, 1992	Substantially Equivalent	Behring Diagnostics, Inc.
K915891	TOXO IGG ELISA TEST (MODIFIED)	Mar 04, 1992	Substantially Equivalent	Gull Laboratories, Inc.
K913505	ENZYGNOST TOXOPLASMOSIS/IGM	Mar 04, 1992	Substantially Equivalent	Behring Diagnostics, Inc.
K914852	ELISA TOXO IGM	Jan 23, 1992	Substantially Equivalent	Sclavo, Inc.
K913787	TOXOPLASMA IGM ELISA TEST SYSTEM	Dec 18, 1991	Substantially Equivalent	Zeus Scientific, Inc.
K913106	ABBOTT IMX TOXO IGM POSITIVE CONTROL	Nov 29, 1991	Substantially Equivalent	Abbott Laboratories
K911834	OPUS(R) ROZO	Aug 12, 1991	Substantially Equivalent	Pb Diagnostic Systems, Inc.
K910416	ABBOTT TOXO-M EIA HIGH POSITIVE CONTROL	Feb 26, 1991	Substantially Equivalent	Abbott Laboratories
K903968	TOXO-CUBE	Dec 18, 1990	Substantially Equivalent	Difco Laboratories, Inc.
K903324	TOXO IGM ELISA TEST	Oct 16, 1990	Substantially Equivalent	Gull Laboratories, Inc.
K902792	TOXOPLASMA GONDII IGG	Jul 24, 1990	Substantially Equivalent	Pharmacia Diagnostics, Inc.
K900818	VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) TOXO.	Apr 30, 1990	Substantially Equivalent	Vitek Systems, Inc.
K900354	TOXO IGG ELISA TEST	Apr 16, 1990	Substantially Equivalent	Gull Laboratories, Inc.
K894948	PLATELIA TOXO IGM KIT	Mar 15, 1990	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K900655	MODIFIED CAPTIA(R) TOXO-M	Mar 06, 1990	Substantially Equivalent	Mercia Diagnostics , Ltd.
K893200	DETECTADOT (TM) SYSTEM 2000 TOXO IGM TEST	Dec 18, 1989	Substantially Equivalent	Gull Laboratories, Inc.
K891781	TOXO ELISA TEST SYSTEM	Jul 14, 1989	Substantially Equivalent	Zeus Scientific, Inc.
K890032	IMX TOXO IGM ANTIBODY ASSAY	Jun 23, 1989	Substantially Equivalent	Abbott Laboratories
K890031	IMX TOXO IGG ANTIBODY ASSAY	Jun 23, 1989	Substantially Equivalent	Abbott Laboratories
K885344	IMMUNOCOMB(TM) TOXOPLASMA IGG ANTIBODY TEST KIT	Apr 12, 1989	Substantially Equivalent	Orgenics, Ltd.
K884249	MODIFIED DDI SEROCARD TOXOPLASMA IGG TEST KIT	Apr 10, 1989	Substantially Equivalent	Disease Detection International, Inc.
K890154	MODIFIED LABYSYSTEMS' TOXOPLASMA GONDII IGG EIA	Feb 07, 1989	Substantially Equivalent	Labsystems, Inc.
K883937	ORTHO* TOXOPLASMA-G ANTIBODY ELISA TEST	Feb 07, 1989	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K883720	TREND(R) EMERGE(TM) TOXOPLASMA IGG ELISA	Jan 24, 1989	Substantially Equivalent	Lmd Laboratories
K883936	ORTHO* TOXOPLASMA-M ANTIBODY ELISA TEST	Oct 06, 1988	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K875258	TOXOPLASMA GONDII IGG ELISA KIT	Sep 30, 1988	Substantially Equivalent	De Ferris Laboratories, Inc.
K880918	CAPTIA TOXO-G	Aug 01, 1988	Substantially Equivalent	Mercia Diagnostics , Ltd.
K875363	SERODOT TOXOPLASMA IGG TEST KIT	Apr 21, 1988	Substantially Equivalent	Disease Detection International, Inc.
K875113	TOXOSTAT M TEST KIT	Apr 12, 1988	Substantially Equivalent	Whittaker Bioproducts, Inc.
K873294	BIOTROL TOXO ELISA TEST G	Apr 12, 1988	Substantially Equivalent	Biotrol, USA, Inc.
K873293	BIOTROL TOXO ELISA TEST M	Apr 12, 1988	Substantially Equivalent	Biotrol, USA, Inc.
K875109	DETECTADOT SYSTEM 2000 TOXO IGG TEST	Mar 07, 1988	Substantially Equivalent	Gull Laboratories, Inc.
K874594	TOXOPLASMA IGM CLIN-ELISA(TM) CAT # 5560	Mar 07, 1988	Substantially Equivalent	Clinical Sciences, Inc.
K872070	CHROMOTITRE E.I.A. TOXOPLASMA IGM	Oct 20, 1987	Substantially Equivalent	Ismunit Istituto Immunologico Intaliano
K871746	CAPTIA(R) TOXO-M: AN ENZYME IMMUNOASSAY	Jul 31, 1987	Substantially Equivalent	Mercia Diagnostics , Ltd.
K871905	TOXOPLASMA GONDII IGG ELISA	Jul 30, 1987	Substantially Equivalent	Electro-Nucleonics Laboratories, Inc.
K872252	MODIFIED TOXOPLASMA GONDII IGG EIA TEST KIT	Jul 01, 1987	Substantially Equivalent	Labsystems, Inc.
K870753	TOXOPLASMA IGM MICROASSAY	Apr 28, 1987	Substantially Equivalent	Diamedix Corp.
K865068	ACCUPOINT TOXO	Feb 20, 1987	Substantially Equivalent	Syva Co.
K863813	TOXOPLASMA IGG MICROASSAY	Nov 28, 1986	Substantially Equivalent	Diamedix Corp.
K863363	CYTOTECH TOXOPLASMA IGG ENZYME IMMUNOASSAY	Nov 13, 1986	Substantially Equivalent	Cytotech, Inc.
K862196	TOXONOSTIKA IGM MICROELISA SYSTEM	Sep 11, 1986	Substantially Equivalent	Organon Teknika Corp.
K862189	ORGANON TEKNIKA TOXONOSTIKA IGG MICROELISA SYSTEM	Sep 08, 1986	Substantially Equivalent	Organon Teknika Corp.
K862216	TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT)	Jun 30, 1986	Substantially Equivalent	Labsystems, Inc.
K861458	MUREX SUDS TOXO	Jun 13, 1986	Substantially Equivalent	Murex Corp.
K860773	TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560	May 23, 1986	Substantially Equivalent	Clinical Sciences, Inc.
K850567	ABBOTT TOXO-M EIA DIAGNOSTIC KIT	Jul 09, 1985	Substantially Equivalent	Abbott Laboratories
K843417	CORDIA T-M	Jan 04, 1985	Substantially Equivalent	Cordis Corp.
K842797	TOXOPLASMA GONDII IGM EIA TEST KIT	Oct 17, 1984	Substantially Equivalent	Labsystems, Inc.
K842528	AMIZYME-TOXOPLASMA GONDII KIT	Sep 07, 1984	Substantially Equivalent	Amico Lab, Inc.
K840879	TOXO-G EIA DIAGNOSTIC KIT	May 21, 1984	Substantially Equivalent	Abbott Laboratories
K833829	TOXOPLASMA GOND II IGG DIA TEST KIT	Apr 24, 1984	Substantially Equivalent	Labsystems, Inc.
K813221	TOXOELISA TEST KIT	Jan 26, 1982	Substantially Equivalent	M.A. Bioproducts